Tissue transfer systems

ABSTRACT

Devices and methods for tissue transfer are described where a cannula may be inserted into the breast of a subject at one of several points of entry. Insertion of the cannula into the breast may be accomplished by using a guidance system to distinguish between tissue types. Once desirably positioned, the cannula may be withdrawn from the breast while automatically (or manually) injecting the fat in multiple deposits of adipose tissue or fat such that the deposited fat remains within the tract formed by the withdrawn cannula. Multiple tracts of the deposited fat may be injected within the breast until the breast has been desirably remodeled and/or augmented.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/371,270 filed Feb. 10, 2012 which claims the benefit ofpriority to U.S. Prov. App. Nos. 61/442,060 filed Feb. 11, 2011;61/489,811 filed May 25, 2011; and 61/510,967 filed Jul. 22, 2011, eachof which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsused for transferring tissue into a region of the body. Moreparticularly, the present invention relates to apparatus and methods fortransferring fat tissue into a region of the body, such as a breast, ina selectively controlled manner.

BACKGROUND OF THE INVENTION

Lipomodeling is a procedure which is typically performed under generalanesthesia. Adipose tissue or fat is usually harvested from one part ofthe body such as the abdomen, buttocks, thighs, etc., and purified toobtain the adipocytes. The purified adipocytes or fat is then injecteddirectly into a targeted region of the subject's body, for example, totreat the face or breasts for augmentation or treatment ofabnormalities. In treating the breasts, the fat is typically injected,e.g., a volume of 100-250 mL per breast, via 10-mL syringes directlyinto the breast and deposited along multiple microtunnels to build up orremodel the breast.

Examples of such procedures are described in Fat Injection to theBreast: Technique, Results, and Indications Based on 880 Procedures Over10 Years, Delay, Emmanuel et al., Aesthetic Surgery Journal, vol. 29,no. 5, 360-376, September/October 2009; Cell-Assisted Lipotransfer forCosmetic Breast Augmentation: Supportive Use of Adipose-DerivedStem/Stromal Cells, Yoshimura, Kotaro et al., Aesth. Plast. Surg., vol.32, 48-55, September 2007; and Fat Grafting to the Breast Revisited:Safety and Efficacy, Coleman, Sydney et al., Plastic and ReconstructiveSurgery, vol. 119, no. 3: 775-785, March 2007, each of which isincorporated herein by reference in its entirety.

During injection of the adipocyte material, the physician will typicallyinject small, discrete quantities into the patient body using aByron-Coleman type re-usable injection cannula. However, this techniqueis subject to variability in physician technique potentially resultingin inconsistent results and is also subject to improper placement of theadipose tissue into undesirable regions within the breast.

The regions within the breast which are ideally avoided by thephysician, such as the muscles or ducts of the breast, may be difficultto discern while the desirable locations for injecting the fat (locatedbetween the pectoral muscles and breast ducts) are also difficult todetect. Prior attempts to accurately position the cannula for injectioninto the ideal locations within the breasts have been made but they havefaced difficulties in use and adoption. Examples are described in, e.g.,A New Technique to Assist Epidural Needle Placement, Ting, Chien-Kun etal., Anesthesiology, vol. 112, no. 5: 1128-35, May 2010, which isincorporated herein by reference in its entirety.

There remains a need for the application of greater volumes implantedinto the breast as well as improved instruments and methods to betterenable fat harvesting, purification, and/or implantation of the fat.Additionally, there remains a need for instruments having improvedguidance for the precision placement of viable adipocyte grafts in thebreast relative to the surrounding breast tissue.

SUMMARY OF THE INVENTION

A cannula may be inserted into the breast of a subject at one of severalpoints of entry. After insertion of the cannula into the breast, thecannula may be withdrawn from the breast while injecting the fat inmultiple deposits of adipose tissue or fat such that the deposited fatremains within the tract formed by the withdrawn cannula. Multipletracts of the deposited fat may be injected within the breast until thebreast has been desirably remodeled and/or augmented.

To properly position the cannula within the breast for injection of thefat, an instrument assembly utilizing diffuse reflectance may beincorporated and may generally comprise a cannula optically coupled to alight source, e.g., laser, etc. via an optical transmission fiber whichis positioned through or adjacent to the cannula. A distal end of thetransmission fiber may emit a light from the distal end of the cannulasuch that any light reflected by tissue in proximity to the distal endmay be detected by the distal end of an optical receiving fiber Thereceiving fiber may be optically coupled to a photo detector which mayin turn by electrically coupled to a processor and a display for use bythe physician.

By transmitting a light (such as laser light having a wavelength ofbetween 600 to 1550 μm) via the transmission fiber onto the tissue, thebackscattered reflected light may be detected by photo detector at adetection range matching that of the transmitted laser output. By havingthe processor differentiate between the different light scatteringproperties of the tissue, the physician can determine whether thecannula is located within or away from a particular anatomical structurefor injecting or refraining from injecting the adipose tissue

With the detection of tissue types utilizing diffuse reflectance, theassembly may be programmed by processor to automatically inject and/orcease injection of the fat from the cannula into the breast dependingupon the type of tissue detected. By utilizing a closed-loop system, asthe cannula is advanced or withdrawn from the breast, the differenttissue types may be automatically detected by processor. When thepresent of fat is detected, cannula may automatically inject the fatfrom cannula in a controlled volume and injection rate.

Aside from tissue identification, the cannula assembly may also be usedfor harvesting of the fat as well as injection into the body. Anoptionally detachable harvesting cannula may be introduced into a regionof the body containing fat to be harvested. The fat may be aspirated orotherwise drawn into the harvesting cannula and collected into aharvesting reservoir assembly having one or more individual cartridges.The collected fat may be processed individually or collectively and thisprocessed fat may be fluidly coupled directly to the handle with yetanother detachable injection cannula.

In addition to the detection of tissue types for facilitating theaccurate injection of the fat, various instruments may be utilizedwithin or in conjunction with the cannula for delivering precise volumesof the fat in a controlled manner. One example is a screw-type injectionmechanism having a fluted shaft. The screw mechanism may be rotatablypositioned within the cannula and it may have a distal opening forinjecting the fat delivered through the cannula. As the screw mechanismrotates, any fat contained within a connected reservoir or within thecannula itself may be meted out through the distal opening. Starting orstopping the injection of the fat may be accurately controlled bystarting or stopping rotation of the mechanism. An optional retractablecover located along the distal end of the cannula may be used as well.

An entry port may be positioned along the handle in proximity to theproximal end of screw mechanism such that fat for injection introducedinto the handle may be taken up by the mechanism. The entry port mayopen into a chamber which is in fluid communication with the cannula andscrew mechanism to minimize any clogging or obstruction which may occurdue to the fat. Additionally and/or optionally, bristle stop members maybe incorporated within the cannula lumen to further minimize or inhibitany clogging of the fat during injection into the patient.

In yet another variation, the injection assembly may optionallyincorporate an impeller-stator assembly within the housing of the handleto help accelerate the fat to a speed sufficient for injection as wellas to uniformly dispense the fat through the cannula for uniforminjection into the breast. In use, as the impeller rotates via a driveshaft, the fat contained within the housing or reservoir may bepropelled distally through the assembly past the blades of the statorwhich remains static. As the fat is urged through the assembly, the flowmay be uniform as it is urged through the cannula for injection into thebreast tissue.

Another variation may include a fat introduction chamber having a firstdiameter D1 from which the cannula extends having a second diameter D2where the diameter of D1 is about twice the diameter of D2. In thisvariation, the chamber may optionally incorporate a plunger topressurize the fat for injection through the cannula while the mechanismrotates to eject the fat.

In yet another variation, a plunger may be positioned within the housingto extend into a proximal portion of the cannula. With the cannulafilled with a quantity of fat, the cannula may be advancedpercutaneously into the breast while under guidance. Once a suitablelocation has been located within the breast, the housing and plunger mayboth be maintained in a static position relative to the breast while thecannula may be retracted into the housing through the opening in thehousing relative to the breast proximally. Because the plunger remainsstatic relative to the cannula, the fat contained within the cannulalumen may be forced out through the distal opening such that the ejectedfat is deposited along the tract previously formed by the cannula withinthe tissue.

Other mechanisms may incorporate a pressure actuated system in which apiston is slidable through the housing by introducing a gas or fluidinto a proximal or distal inlet to urge the piston proximally within thehousing thereby retracting cannula or distally out of the housing.

Instead of utilizing a pressure driven assembly, another injectionassembly variation may use a linear threaded member which is rotatablycoupled to a motor positioned within a housing. Here, the motor mayrotate the threaded member in either direction to urge a carriage whichis threaded in a corresponding manner to move distally or proximallyalong the threaded member depending upon the direction of rotation bythe threaded member. The carriage may be attached to a proximal end ofthe cannula such that as the carriage travels along the threaded memberthe cannula may be retracted or extended as desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a cross-sectional side view of a cannula inserted into abreast of a subject and depositing adipose tissue.

FIG. 1B shows an anterior view of a representative breast and possiblepercutaneous entry points and pathways for depositing adipose tissue.

FIGS. 1C and 1D show examples of how the cannula may be inserted througha single entry point beneath a breast for remodeling the breast withdeposited fat.

FIG. 1E shows a cross-sectional side view of a breast with areas ofbreast tissue which are typically to be avoided when depositing adiposetissue.

FIGS. 1F to 1H illustrate cross-sectional areas of a breast where aninjection cannula has been advanced at varying angles and at differentlocations for potential fat deposition.

FIG. 2A shows a representative assembly in one variation of animplantation instrument which may be guided within the body by diffusereflectance.

FIG. 2B shows another variation of a guidance assembly having an opticalfiber probe.

FIG. 2C shows an example of an optoelectronic module which may beintegrated with the guidance assembly.

FIG. 2D shows a perspective view of an example of an injection cannulahaving the light transmission and light receiving fibers within thedistal end for tissue characterization.

FIG. 2E shows a cross-sectional side view of another example of thecannula having the injection lumen passing through with one or moreoptical fibers positioned through the cannula.

FIGS. 2F to 2I show end views of exemplary embodiments for positioningof the optical fibers for excitation as well as detection.

FIGS. 2J to 2N show various configurations for the excitation source anddetection assembly which may be used with the guidance assembly.

FIG. 3A shows an example of the variance in signal intensity uponencountering different tissue types for facilitating the selectivedeposition of adipose tissue.

FIG. 3B shows a cross-sectional side view of an instrument which may beguided via the signal variance for selectively depositing the adiposetissue.

FIG. 4A shows a perspective assembly view of a cannula assembly whichmay be used for harvesting and collecting fat from within a body.

FIGS. 4B and 4C show perspective and cross-sectional side views ofanother variation of a cannula assembly used for harvesting and/orinjection.

FIG. 4D show side views of various harvesting cannulas.

FIG. 4E shows an assembly view of a harvesting reservoir assembly havingone or more individual reservoirs or cartridges.

FIG. 4F shows a perspective view of one variation of an instrumenthaving an internal screw-type mechanism for controlling the delivery ofthe tissue into the body.

FIG. 5 shows a cross-sectional side view of another variation of aninstrument having an internal screw-type mechanism coupled to apressurizable reservoir.

FIG. 6 shows a cross-sectional side view of an instrument shaft having aretractable distal tip.

FIGS. 7A to 7C show perspective views of the instrument shaft, handle,and tip, respectively, having a screw-type mechanism.

FIGS. 8A to 8C show side views and detailed perspective views of aninstrument having a screw-type mechanism.

FIGS. 9A to 9C show perspective detailed views of an instrument shaftincorporating projections, such as bristles, within the cannula shaftfor functioning as a stop mechanism to the adipose material and tofacilitate the linear movement of the material through the shaft lumen.

FIG. 10 shows a side view of one variation of an impeller and statormechanism for facilitating adipose tissue movement within the instrumentas well as uniformly dispensing the tissue material from the cannula.

FIG. 11 shows a side view of another variation of an impeller and statormechanism.

FIGS. 12A to 12F show examples of various impeller configurations whichmay be used with the injection instrument.

FIG. 13 shows a representative example of another variation of aninstrument having an introduction chamber for receiving the adiposetissue for injection.

FIG. 14 shows one variation of a reservoir which may be used tointroduce the adipose material into an injection instrument.

FIG. 15 shows a detailed cross-sectional side view of an inlet port forreceiving the adipose material into the cannula for injection.

FIG. 16A shows a cross-sectional side view of another variation of aninjection instrument having at least two sections with differingdiameters as well as a pressurizing mechanism, such as a piston, toinhibit clogging of the adipose material during injection.

FIG. 16B shows a perspective view of a dual-diameter injectioninstrument.

FIG. 16C shows a cross-sectional side view of another variation of adual diameter injection instrument.

FIGS. 17A and 17B show side views of another variation of an injectioninstrument having a retractable cannula.

FIG. 18A shows a cross-sectional side view of another variation of aninjection instrument having a collapsible inner sheath within a cannula.

FIGS. 18B and 18C show side views of a retraction mechanismreconfigurable within the cannula.

FIG. 19A shows a side view of another example of a needle cannula havinga piston assembly.

FIGS. 19B to 19D show side views of the needle cannula retractingrelative to a breast to deposit a tract of adipose tissue within thebreast.

FIGS. 20A and 20B show side views of another variation of an injectioninstrument which may be pressure actuated.

FIGS. 21A and 21B show side views of another variation where theinjection instrument may be driven by a lead screw-type mechanism.

FIG. 22 shows another variation of an injection instrument using apressurized mechanism.

FIGS. 23A to 23C show perspective and side views of another variationusing a lead screw-type mechanism with a retractable needle cannula.

FIGS. 24A and 24B show perspective views of the instrument having aretractable needle cannula.

FIGS. 25A and 25B show detail side views of the retractable needlecannula mechanism.

FIGS. 26A to 26C show perspective views of another variation where theretractable needle may be refilled once retracted.

FIG. 27 shows a cross-sectional side view of an in-line filtrationsystem which may be integrated with an injection instrument.

FIGS. 28A to 28C show perspective views of alternative variationsinjection instruments configured to have multiple cannulas and/orinterchangeable cannulas.

FIGS. 29A and 29B show perspective views of yet another variation havingmultiple cannulas where each successive cannula may have a length whichis shorter to facilitate injection within a contoured body region suchas a breast.

FIGS. 30A and 30B show perspective views of yet another variation wherethe fiber optic connection may be detachable from the system andreconnected in an axial arrangement.

FIG. 31 shows a schematic illustration of an example of a completeharvesting, processing, and injection system which is coupled to oneanother such that a consistent and relatively low pressure may bemaintained throughout the entire process and system.

FIG. 32 shows an assembly view of a combined fat harvesting andinjection assembly utilizing a single handle and controller.

FIG. 33 shows an assembly view of another example illustrating how thehandle with a detachable harvesting cannula may be used for harvestingthe fat for processing and then used also for injection into the patientbody with a detachable injection cannula.

FIG. 34 shows an assembly view of another example of how an individualcartridge having processed fat may be coupled directly into the handlefor injection into the body.

FIGS. 35A and 35B show perspective views of another variation of ahandle assembly attached to an injection cannula and further having anangled receiving section for receiving an individual cartridge havingprocessed fat for injection.

FIGS. 36A to 36J show various views of yet another variation of a handleassembly which may be configured as a portable and self-containeddevice.

FIGS. 37A and 37B show perspective views of another variation of thehandle assembly illustrating how the handle may be separated into atleast two components.

FIGS. 38A and 38B illustrate perspective views of another variation of ahandle assembly which may also comprise a resusable component as well asa disposable component having an angled section.

FIG. 39A schematically illustrates one example of how the individualcartridges may be filled with the harvested fat collected from theharvesting cannula.

FIG. 39B schematically illustrates an example of how the individualcartridges may be purged of air or other material and incorporated intothe injection assembly.

FIG. 40 shows a perspective view of one configuration of cartridgescoupled to a base dock.

FIG. 41 shows a cross-sectional side view illustrating one configurationfor a valve and plunger assembly incorporated into a cartridge.

FIGS. 42A and 42B show cross-sectional side and perspective views of onevariation of a plunger defining one or more openings therethrough.

FIG. 43 shows a side view of a cartridge having a plunger and valveassembly incorporated.

FIGS. 44A and 44B show cross-sectional side views of a plunger and valveassembly illustrating an open and closed configuration.

FIG. 45 shows a partial cross-sectional side view of a plunger and valveassembly coupled to a port adapter.

FIG. 46 shows a perspective view of another variation of a plunger andvalve assembly integrated with a key for maintaining a position of theplunger.

FIG. 47 shows a perspective view of an example of a port adapter.

FIGS. 48A and 48B show respective side and schematic views of an exampleof a reversible pump assembly which may be integrated into any of thehandle variations described herein.

FIG. 49 shows a side view of another variation of the reversible pumpassembly.

FIG. 50 shows a graph of the travel distance of the piston relative tothe current drawn by the motor.

FIG. 51A shows a perspective view of yet another variation of acontinuous pump assembly removed from the handle for clarity.

FIGS. 51B and 51C show cross-sectional side and end views, respectively,of the pump assembly with the circuit assembly removed for clarity.

FIG. 52A shows an end view of the pump assembly of FIG. 51A.

FIGS. 52B to 52D show the pump assembly of FIG. 51A with the handlehousing removed for clarity.

FIGS. 53A to 53C show detailed side views of the proximal body toillustrate corresponding use of the proximal and distal sensors withinthe pump assembly.

FIG. 54 shows a partial cross-sectional side view of the pump assemblyand details of the interrupter assembly.

FIG. 55A shows another perspective view of the pump assembly with thecircuit assembly removed for clarity.

FIGS. 55B to 55D show side and end views of the components of the mainchamber and distal cap.

FIGS. 55E and 55F show side and end views of a representative duckbill-type valve oriented to prevent or inhibit tissue from bindingagainst the valve.

FIGS. 55G to 55I show side and end views of a representativeflapper-type valve oriented to prevent or inhibit tissue from bindingagainst the valve.

FIGS. 56A to 56C illustrate how the plunger may be initiated in a primedposition and home position and subsequently stepped to deliver acontrolled volume of aliquots.

FIGS. 57A and 57B show detail side views of the enlarged priming borediameter for clearing air or debris from the pump assembly.

FIGS. 58A and 58B show a detail side and perspective views of the angledchannel and luer block within the handle assembly.

FIG. 58C shows an end view of the luer block contained within the handleassembly.

DETAILED DESCRIPTION OF THE INVENTION

As shown in the cross-sectional side view and anterior view of FIGS. 1Aand 1B, a cannula 10 may be inserted into the breast BR of a subject atone of several points of entry 14 in proximity to the nipple andcircumference of the breast BR. After insertion of the cannula 10 intothe breast, the cannula 10 may be withdrawn from the breast BR whileinjecting the fat in multiple deposits of adipose tissue or fat 12 suchthat the deposited fat 12 remains within the tract 16 formed by thewithdrawn cannula 10. Multiple tracts 16 of the deposited fat 12 may beinjected within the breast utilizing the common entry points 14 untilthe breast has been desirably remodeled and/or augmented.

FIGS. 1C and 1D illustrate an example of how the cannula 10 may beinserted into a single entry point 14 beneath the breast BR and how thefat 12 may be deposited along a tract defined by the cannula 10. Withthe cannula 10 positioned through the entry point 14 within the breastBR, the cannula 10 may be repeatedly advanced and withdrawn alongmultiple tracts 16 through the common entry point 14 while depositingfat to remodel the breast BR accordingly.

However, the physician may encounter difficulties discerning when andwhere the fat can be deposited within the breast BR. FIG. 1E shows across-sectional side view of breast BR illustrating areas of breasttissue to be avoided 18, such as within the underlying muscles or ducts,and the targeted deposit area DA which is typically within thesubcutaneous fat layer within the breast BR located between the pectoralmuscles and the ducts.

FIGS. 1F to 1H illustrate cross-sectional areas of a breast BR when thecannula 10 has been advanced at varying angles and at differentlocations where fat may or may not be deposited. For instance, FIGS. 1Fand 1G illustrate how the cannula has been advanced into tissue regionsto be avoided 18, the cannula 10 may detect the tissue type (asdiscussed further herein) and give an indication as to the desirabilityof the location for fat deposition. FIG. 1H illustrates an example ofwhen the cannula 10 may be advanced into a desirable area within thebreast BR for fat deposition.

Thus, in properly positioning the cannula within the breast forinjection of the fat, one example of an instrument assembly 20 utilizingdiffuse reflectance is shown in the cross-sectional assembly view ofFIG. 2A. As illustrated, assembly 20 may generally comprise a cannula 22which may be optically coupled to a light source 24, e.g., laser, etc.via an optical transmission fiber 26 which is positioned through oradjacent to cannula 22. A distal end of the transmission fiber 26 mayemit a light from the distal end 30 of the cannula such that any lightreflected by tissue in proximity to the distal end 30 may be detected bythe distal end of an optical receiving fiber 28. The receiving fiber 28may be optically coupled to a photo detector 32 which may in turn byelectrically coupled to a processor 34 and a display 36 for use by thephysician.

By transmitting a light (such as laser light having a wavelength ofbetween 600 to 1550 μm) via transmission fiber 26 onto the tissue, thebackscattered reflected light may be detected by photo detector 32 at adetection range matching that of the transmitted laser output, e.g.,ranging up to 50 mW or more. Other suitable wavelengths for the laserlight may range, e.g., between 630 to 1450 nm, as many biologicaltissues have a low absorption window which is away from hemoglobinabsorption. Also, such a range may avoid water absorption in the NIRrange. Moreover, Rayleigh scattering and Mie scattering may allow for adiffuse reflectance of deep penetrating and back-scattered photons.Another suitable range may include, e.g., 920±10 nm or 1210±10 nm. Laserlight wavelengths in such a range may help to differentiate againstnon-lipid containing tissues when combined with other wavelengths.

Various types of lasers may be used (e.g., superluminescent emittingdiode (SLED) lasers, etc.) at multiple wavelengths to highlight thedifferences in tissue structures. The photo detector 32 may convert theinput signal to an output voltage which is then transmitted to processor34 which may be programmed to differentiate the physiologic structuresbased on the light scattering properties and light reflectance intensityat various wavelengths. The diffuse reflectance may be optionallyutilized in combination with other detection modalities such asultrasound, optical coherence reflectometry, etc.

FIG. 2B shows another variation of a guidance assembly 21 which may havea cannula 22 (for tissue harvesting or injection) through which theinjection lumen 29, in this example, may be defined and an optical fiberprobe 23, as described above. The assembly 21 may also include a flowsensor 25 as well as an actuator assembly 27 integrated into theassembly 21. An optical cable 31 may couple the optical fiber probe 23to an optoelectronic (OE) module 33 containing the excitation source,e.g., laser source, as well as the detection electronics. A cable 35 maycouple the OE module 33 with a display 36.

An example of an OE module 33 is shown schematically in FIG. 2C whichillustrates the optical cable 31 connected to an optical system assembly39 comprising the excitation source, optical circuitry, detector(s),source driver, etc. An electronics assembly 41 (e.g., interface bus,digital signal processor, buffer/memory, A/D converter, DAQ (digitalacquisition) module, etc.) may communicate with the optical systemassembly 39 and a power supply 37 may also be included. The cable 35 maybe electrically coupled to the electronics assembly 41 leading to thedisplay or another module. Additionally, the flow sensor 25 may also beseen in electrical communication with the electronics assembly 41 aswell.

FIG. 2D illustrates a perspective view of an example of a cannula wherethe transmission fiber 26 may emit the light 27 onto the adjacent tissueregion. The optical receiving fiber 28 is also shown within the cannuladistal end 30 receiving the reflected light 29 with informationindicative of the tissue type.

FIG. 2E shows a cross-sectional side view of another example of thecannula 22 having the injection lumen passing through with one or moreoptical fibers positioned through the cannula 22. FIGS. 2F to 2I showend views of exemplary embodiments for positioning of the optical fibersfor excitation as well as detection. FIG. 2F shows one example where theexcitation source fiber 43 may be positioned adjacent to thefluorescence emission sense fiber 45. A diffuse reflectance sense fiber47 may be positioned in proximity to the excitation source fiber 43 fordetecting the reflected diffused light 49 as well as any fluorescence 51which may be excited from the illuminated tissue.

FIG. 2G shows another variation where the excitation source fiber 43 andfluorescence emission sense fiber 45 may be combined into a singleoptical fiber or fiber bundle. FIG. 2H shows yet another variation wherethe excitation source fiber 43 and fluorescence emission sense fiber 45may be combined again but the reflectance sense fiber 47 may bepositioned adjacent to the combined fiber or fiber bundle. FIG. 2I showsa similar variation where the excitation source fiber 43, fluorescenceemission sense fiber 45, and reflectance sense fiber 47 may all becombined into a single fiber or fiber bundle.

Turning now to the optical system assembly 39, the excitation source anddetection assembly may be positioned into various configurations. FIG.2J shows one variation in optical system assembly 39A where theexcitation source may be combined into a single signal includingλ_(source) (e.g., from a first laser source LD1) and λ_(ex) (e.g., froma second laser source LD2). The diffuse reflectance λ_(Rd) as well asthe fluorescence emission λ_(em) may be received back into the opticalsystem assembly 39 where the signal may be split, e.g., via dichroicmirrors, for detection of the fluorescence emission λ_(em) by a firstdetector DET1 and of the diffuse reflectance λ_(Rd) by a second detectorDET2 for processing by the electronics assembly 41.

FIG. 2K shows another variation where the fluorescence emission λ_(em)may be filtered and detected, e.g., by a line detector DET1. FIG. 2Lshows another variation where the excitation source λ_(source), λ_(ex)may be combined into a single signal and where the same fiber or fiberbundle may be used to detect the diffuse reflectance λ_(Rd) which may befiltered for detection by DET1 while the fluorescence emission λ_(em)may be detected in a separate fiber or fiber bundle by second detectorDET2. FIG. 2M shows yet another variation where the excitation sourceλ_(source), λ_(ex) and diffuse reflectance λ_(Rd) may be detected via asingle fiber or fiber bundle, as above, but where the fluorescenceemission λ_(em) may be detected in a manner similar to the configurationshown in FIG. 2K above. FIG. 2N shows yet another variation where theexcitation source source λ_(source), λ_(ex) and detected diffusereflectance λ_(Rd) and fluorescence emission λ_(em) may be combined intoa single fiber or fiber bundle. The detected signal may be filtered fordetection by DET1 and DET2 as shown.

The tissue guidance assemblies described may be integrated into any ofthe harvesting and/or injection cannulas described herein to helpdistinguish between different tissue types when harvesting tissue and/orinjecting processed tissue into the body.

By having the processor 34 differentiate between the different lightscattering properties of the tissue, the physician can determine whetherthe cannula 20 is located within or away from a particular anatomicalstructure for injecting or refraining from injecting the adipose tissue.An example is illustrated in the graphical interface of FIG. 3A whichshows the reflectance intensity 40 of the tissue encountered by thecannula 22. Such a graph 40 may be displayed to the physician to providea real time indication of cannula position during a procedure. In thisexample, as the cannula 22 approaches the skin surface, an initial noisefloor 42 indicative of the presence of the cannula in air may beinitially shown, as illustrated in FIG. 3B.

As the cannula 22 approaches and is inserted into the skin 1, the signalintensity may rise indicating to the physician that the cannula 22 hasentered the skin 1. As the cannula 22 is advanced into the breast BR,the different layers of tissue may be detected and charted. Forinstance, as the cannula 22 enters adipose tissue or fat 2 within thebreast, the signal intensity may drop to a level between the initialsignal 42 and the signal sensed from the skin 1. This detected level mayindicate to the physician that they are within a region of the breast BRwhere fat may be injected. Other tissue structures such as ligament 3 ormuscle 4 may be reflected and charted accordingly where each differenttissue type may generate its own level of signal intensity. In the eventthe cannula 22 detects tissue types other than fat 2, the processor 34may be programmed to signal some visual or auditory alarm indicatingthat the cannula 22 may need repositioning. In the event that the signaldrops to the noise floor 44, this may indicate that the cannula 22 hasadvanced between or has been withdrawn from the breast BR.

With the detection of tissue types utilizing diffuse reflectance, theassembly may be programmed by processor 34 to automatically injectand/or cease injection of the fat from the cannula 22 into the breastdepending upon the type of tissue detected. By utilizing a closed-loopsystem, as the cannula 22 is advanced or withdrawn from the breast, thedifferent tissue types may be automatically detected by processor 34.When the present of fat is detected, cannula 22 may automatically injectthe fat from cannula 22 in a controlled volume and injection rate. Inthe event that the system detects a position of the cannula 22 in tissuetypes other than fat, such as muscle, the processor 34 may automaticallycease the injection into the breast until the presence of fat is againdetected within the breast in which case the processor 34 mayautomatically resume the injection of the fat. Alternatively, ratherthan utilizing an automated system, an alarm or indication may beindicated to the physician who may manually inject and/or cease theinjection of the fat from the cannula into the breast.

Moreover, with a cannula having a size ranging anywhere from 16-10 gauge(or higher), a typical volume of fat ranging from, e.g., 10-20 cc, maybe accomplished. With such a volume injectable per cannula, the amountof fat injected during an entire procedure within, e.g., a breast, mayvary from, e.g., 100-1000 cc per breast, or an average of, e.g., 450 ccper breast.

While the cannula 22 may be traversed through the body at various rates,e.g., up to 10 cm/sec, the withdrawal rates for the cannula 22 may varyas well. For example, the cannula may be retracted at rates of, e.g., 2mm/sec up to 5 cm/sec, and the cannulas may optionally incorporate ahydrophilic coating along its length to facilitate the advancement orwithdrawal through the tissue. Moreover, the cannulas may optionallyoscillate (automatically or manually) to facilitate injection of thefat.

The identification of tissue type may be used not only for fat injectioninto the body, but it may also be used in identifying desirable tissueregions for the harvesting of the fat from the body for processing priorto re-injection.

One variation is illustrated in the perspective assembly view of FIG. 4Ashowing cannula assembly 31 which illustrates a handle 33 for providingthe harvesting of the fat from the body as well as the injection intothe body. An optionally detachable harvesting cannula 35 is shownextending from the handle 33 and defining one or more openings orfenestrations 37A to 37C along the cannula 35 near the distal end. Eachof the openings 37A to 37C may be staggered or uniform relative to oneanother. Moreover, although three openings are shown, this is merelyexemplary and a fewer or greater number of openings may be defined alongthe cannula 35. A rotatable inner shaft 39 may be positioned within thecannula with a number of cutting windows 41A to 41C which correspond inposition and size with respect to the openings 37A to 37C along thecannula 35.

In use, the inner shaft 39 may be rotated relative to a stationarycannula 35 such that the when the openings are aligned, adjacent fat maybe introduced within the openings and then cut or shaved into thecannula 35 as the inner shaft 39 rotates and closes the openings ontothe fat with respect to the cannula 35. The cut or shaved fat may bedrawn through the cannula 35 and handle 33 and through a tubing 43 whichis in fluid communication with a harvesting reservoir assembly 45 whichmay contain one or more individual reservoirs or cartridges 47. Theindividual cartridges 47 containing the collected fat and other tissuemay be further processed and directly introduced into the patient'sbody, such as the breasts, for remodeling the body.

FIGS. 4B and 4C show perspective and partial cross-sectional side viewsof another variation of a cannula assembly 49 which may be used forharvesting and/or injection. The assembly 49 illustrates a harvestingcannula 35 with one or more openings 37 defined near the distal end ofthe cannula 35. The handle 33 in this variation further illustrates anopening 51 along the side of the handle 33 into which a reservoir orcartridge 47 or tubing may be fluidly coupled to transfer and/or collectthe aspirated fat for further processing or re-injection.

FIG. 4D illustrate side views of various harvesting cannulas 35 whichhave a variable number of openings 53 for collecting the fat. As shown,the number of openings 53 may be varied from a few, e.g., threeopenings, to several openings 55, e.g., six openings.

An example of the harvesting reservoir assembly 45 is illustrated in theperspective view of FIG. 4E which shows assembly 45 fluidly coupled to aharvesting cannula. As described above, the reservoir assembly 45 maycontain one or more individual reservoirs or cartridges 47 each fluidlycoupled. The tubing 43 coupled to the harvesting cannula may draw in thecollected fat 59 and other fluids or tissue 57 directly into the one ormore cartridges 47 thus increasing the viability of the collected fat byreducing exposure to air and mechanical trauma as well as reducing theamount of time spent outside the patient's body.

The one or more cartridges 47 may be individually or collectivelyprocessed and the miscellaneous fluids or tissue 57 may be removed fromthe cartridge 47, e.g., via an opening 61 located along the cartridge47. The resulting processed cartridge 47A may retain only the desiredfat tissue 59 for direct injection into the patient body by utilizingthe cartridge 47A directly with the injection assembly.

In addition to the detection of tissue types for facilitating theaccurate harvesting or injection of the fat, various instruments may beutilized within or in conjunction with the cannula for deliveringprecise volumes of the fat in a controlled manner. One example is shownin the perspective view of FIG. 4F which illustrates a screw-typeinjection mechanism 50, such as a screw mechanism 58 having a flutedshaft. The screw mechanism 58 may be rotatably positioned within cannula52 which may also have a tapered piercing tip 54 and a distal opening 56for injecting the fat delivered through the cannula 52. As the screwmechanism 58 rotates, any fat contained within a connected reservoir orwithin the cannula 52 itself may be metered out through the distalopening 56. Starting or stopping the injection of the fat may beaccurately controlled by starting or stopping rotation of the mechanism58.

Another variation is illustrated in the cross-sectional side view ofinjection instrument 60 shown in FIG. 5. In this variation, an outersheath or cannula 62, e.g., 20 gauge, which may range from, e.g., 6-12inches in length, may be operatively connected to a handle 68 and mayalso be in fluid communication with a reservoir 76 containing a volumeof the adipose tissue or fat 78. A fluted mechanism 64 may be rotatablypositioned within a lumen defined through the cannula 62 and a piston 74may also be incorporated into the reservoir 76 for optionallypressurizing the fat 78 for facilitate injection through the cannula 62.An air inlet port 70 and an air outlet port 72 may also be optionallyincluded along handle 68 for controlling the air within the device aspiston 74 is actuated.

FIG. 6 shows a detailed cross-sectional side view of the cannula 62 fromFIG. 5 with an optional retractable cover 82 located along the distalend 66 of the cannula 62. In use, once the cannula 62 has been advancedand desirably positioned within the breast BR for fat injection usingthe transmission fiber 26 and receiving fiber 28 described above, thepiston 74 may be optionally actuated and the fluted mechanism 64 may beactuated to rotate such that the fat 78 is advanced distally through thelumen 80 of cannula 62. The one or more members of optional cover 82 (ifpresent) may be retracted, as shown, to reveal the distal opening 84 oflumen 80 allowing for the injection of the fat 78 into the breasttissue.

Another example of an injection assembly is shown in the perspectiveviews of FIGS. 7A to 7C. Cannula 62 is shown with fluted mechanism 64rotatably positioned within. Distal end 66 is shown having optionallyretractable members 92 which form an atraumatic rounded tip when closedfor advancement through tissue. However, when fat is ejected fromcannula 62, the retractable members 92 may open to allow for theinjection of the fat. An entry port 90 for introducing adipose tissueinto the handle 68 is also shown where the entry port 90 may be locatedin proximity to a proximal end of the fluted mechanism 64.

As illustrated in the side and perspective views of FIGS. 8A to 8C, theentry port 90 may be positioned along the handle 68 in proximity to theproximal end of mechanism 64 such that fat for injection introduced intothe handle 68 may be taken up by the mechanism 64. The entry port 90 mayopen into a chamber which is in fluid communication with the cannula 62and mechanism 64 to minimize any clogging or obstruction which may occurdue to the fat.

To further minimize or inhibit any clogging of the fat during injectioninto the patient, FIGS. 9A to 9C show perspective and side views of oneor more bristle stop members 100 which may be positioned attached alongthe lumen of cannula 62. The bristle stop members 100 may generallycomprise bristles or projections 106 which are attached along anattachment length 104 along the lumen and extend into the lumen and actas a stop for fat reducing radial travel and may function to increasethe translational linear movement of the fat through the cannula 62without inhibiting the rotational movement of the mechanism 64 adjacentto the bristles 106. The bristles 106 may extend along the lumen indiscrete segments, as shown in FIG. 9A, or as a continuous bristlemember 102, as shown in FIG. 9B.

In yet another variation, the injection assembly may optionallyincorporate an impeller-stator assembly 110, as shown in the partialcross-sectional side view of FIG. 10, within the housing of the handleto help accelerate the fat to a speed sufficient for injection as wellas to uniformly dispense the fat through the cannula 62 for uniforminjection into the breast. Generally, an impeller-stator assembly 110may have an impeller 112 which has one or more blades extending radiallyfrom a hub and is rotatable relative to the cannula 62. A stator 114which remain static relative to the assembly may be located distal tothe impeller 112 and may also have one or more stator blades 116 whichextend radially from its hub to facilitate the uniform distribution ofthe fat passing through the assembly 110.

In use, as shown in the example of FIG. 11, as the impeller 112 rotatesvia a drive shaft 120, the fat contained within the housing or reservoirmay be propelled distally through the assembly past the blades 116 ofthe stator 114 which remains static. As the fat is urged through theassembly, the flow may be uniform as it is urged through the cannula 62for injection into the breast tissue. FIGS. 12A to 12F show examples ofvarious impeller configurations 132, 134, 136, 138, 140 which may beused in the impeller-stator assembly 110.

FIG. 13 shows yet another variation of an injection assemblyincorporating a fat introduction chamber 150 within the housing of thehandle. The introduction chamber 150 may be positioned proximally of thecannula 62 with an entry port 152 which opens above a proximal end ofthe fluted mechanism 64 when the assembly is held upright. One or moreintroduction lumens 154 may open into the introduction chamber 150 forreceiving the fat from a reservoir 160, as shown in the side view ofFIG. 14. The reservoir 160 may be optionally pressurized via, e.g., aplunger 162, and fluidly coupled to the introduction chamber 150 viatube 158 which may optionally divide into one or more transfer lumens156. As the mechanism 64 is actuated by drive shaft 120 (which may beautomatically controlled by processor 34, as previously described), fatmay be urged from the pressurized reservoir 160 to transfer into theintroduction chamber 150 and then into contact with the proximal end ofmechanism 64 through entry port 152, as shown in the detailcross-sectional side view of FIG. 15, for injection into the subject'sbreast.

Another variation is shown in the partial cross-sectional side view ofFIG. 16A, which shows a fat introduction chamber 170 having a firstdiameter D1 from which cannula 62 extends having a second diameter D2where the diameter of D1 is about twice the diameter of D2. In thisvariation, chamber 170 may optionally incorporate a plunger 172 topressurize the fat for injection through the cannula 62 while mechanism64 rotates to eject the fat. FIG. 16B shows a perspective view of theassembly and FIG. 16C shows another variation in the partialcross-sectional side view which incorporates an optional port 174 forallowing air to enter or exit during pressurization of the fat withinchamber 170.

In yet another variation, FIGS. 17 and 17B show representative partialcross-sectional side views of an injection assembly 180 having a housing182 with a retractable cannula 184 which may be withdrawn partially orentirely into the housing 182 during fat injection. A plunger 186 may bepositioned within housing 182 to extend into a proximal portion ofcannula 184. With cannula 184 filled with a quantity of fat 78, cannula184 may be advanced percutaneously into the breast while under guidance(as previously described). Once a suitable location has been locatedwithin the breast, housing 182 and plunger 186 may both be maintained ina static position relative to the breast while cannula 184 may beretracted into the housing 182 through opening 188 in housing 182relative to the breast proximally. Because the plunger 186 remainsstatic relative to the cannula 184, the fat 78 contained within thecannula lumen 192 may be forced out through the distal opening 190 suchthat the ejected fat 78 is deposited along the tract previously formedby the cannula 184 within the tissue.

FIG. 18A shows another variation of the retractable cannula 184 havingan actuation shaft 200 positioned within the cannula lumen. Theactuation shaft 200 may have a support shaft 202 which extends throughthe cannula with one or more collapsible barbs 204 extending radiallyfrom the shaft 202. Boluses of fat 78 may be positioned between each ofthe barbs 204 which may help to compact the fat within the cannula 184and prevent any buildup or introduction of air within the fat 78. FIGS.18B and 18C show detail side views of one variation of the barbs 204which may project at an acute angle relative to the shaft 202 such thatthe barbs 204 are angled to extend distally along the cannula 184. Whenshaft 202 is retracted proximally, each of the barbs 204 may pivot via apivoting attachment 206 to collapse against shaft 202 to allow for theinjection of the compacted fat 78 from distal opening 190 into thebreast tissue.

In yet another variation, FIG. 19A shows a representative side of aretractable cannula 184 (e.g., a 10 gauge needle cannula) having aninner piston shaft 210 which is translatable relative to the cannula184. Piston shaft 210 may define a lumen 212 therethrough within which avolume of fat 78 may be placed. An example of use is shown in the sideviews of FIGS. 19B to 19D which illustrate how the needle cannula 184may be retracted relative to the piston shaft 210 prior to percutaneousinsertion into the breast BR, as shown in FIG. 19B. Prior to, during, orafter the cannula 184 has been advanced into the breast BR and desirablypositioned for injection (e.g., using the guidance devices and methodsdescribed herein), cannula 184 may be extended relative to the shaft 210and a volume of fat 78 may be introduced into the cannula 184 throughthe lumen 212 of shaft 210, as shown in FIG. 19C. Once the volume of fat78 is ready for injection into the breast BR, the cannula 184 may beretracted from the breast BR while maintaining a position of the shaft210 relative to the breast BR such that a volume of fat 78 is injectedinto the breast BR along the tract formed by the withdrawn cannula 184,as shown in FIG. 19D.

FIGS. 20A and 20B show side views of another variation of an injectionassembly 220 which comprise a pressure actuated system. In thisvariation, cannula 184 may be attached at a cannula attachment 224 to amovable piston 226 which is slidable through the housing 182. A volumeof fat may be introduced into the cannula 184 in its extendedconfiguration which may be extended by introducing a gas or fluid intothe proximal inlet 222, as shown in FIG. 20B. Once the cannula 184 hasbeen desirably positioned within the breast BR, the cannula 184 may beretracted proximally into the housing 182 by introducing a gas or fluidinto the distal inlet 222′ to urge the piston 226 proximally within thehousing 182 thereby retracting cannula 184, as shown in FIG. 20B.

Instead of utilizing a pressure driven assembly, another injectionassembly 230 variation shown in the side views of FIGS. 21A and 21B mayuse a linear threaded member 232 which is rotatably coupled to a motor234 positioned within a housing. Here, the motor 234 may rotate thethreaded member 232 in either direction to urge a carriage 236 which isthreaded in a corresponding manner to move distally or proximally alongthe threaded member 232 depending upon the direction of rotation by thethreaded member 232. Carriage 236 may be attached to a proximal end ofcannula 184 such that as the carriage 236 travels along the threadedmember 232 the cannula 184 may be retracted, as shown in FIG. 21A, orextended, as shown in FIG. 21B, as desired. A reservoir 238 (which maybe pressurized) may be fluidly coupled to a proximal end of the cannula184 so as to provide a volume of fat for injection through the cannula184.

FIG. 22 shows a partial cross-sectional side view of another injectionassembly 240 variation which utilizes a pressurized cannula actuationsystem. Handle housing 242 may comprise a pressurizable line 244 whichmay be pressured at either a proximal inlet 246 or at a distal inlet246′ to actuate a piston attached to the cannula 184. Depending uponwhich inlet 246, 246′ is pressurized, the cannula 184 may be retractedor extended for advancement into the breast and injection of fataccordingly.

In yet another variation, FIGS. 23A to 23C show perspective and sideviews of an injection assembly 250 variation which utilizes a rotatablelead screw 232 to advance or retract a carriage 236 attached to aproximal end of cannula 184, similar to the variation described above inFIGS. 21A and 21B. In this example, handle housing 252 may contain apower supply 254 for driving the motor 234 to rotate the lead screw 232.FIGS. 24A and 24B show perspective views of the assembly 250 and FIGS.25A and 25B show detail side views of the extension and retraction,respectively, of the carriage 236 to extend and retract the cannula 184within housing 252 for injecting the fat. The retractable cannula may beutilized in any number of various cannula embodiments as describedherein.

FIGS. 26A to 26C show perspective views of another variation of aninjection assembly 260 which may comprise a handle housing 262 intowhich cannula 184 may be retracted using any of the mechanisms describedherein. Housing 262 may incorporate a valve proximal to the opening 188which may close once the cannula 184 has been retracted into housing262, as shown in FIG. 26B, to allow the cannula 184 to be refilled withfat. Once the cannula 184 is ready to be retracted once again, the valvemay be opened and the cannula 184 extended. In this as well as any ofthe injection instrument embodiments described herein, the tissuedetection assemblies may be incorporated as desired.

As previously mentioned, fat may be harvested from a first site of thepatient (e.g., periumbilical, lumbar, trochanteric, thigh, medial kneeand arm, etc.) and this harvested fat may be purified prior to injectionback into the patient. When harvesting the fat, the patient may beanesthetized and the lipoaspiration procedure may be performed.

While extraction may be performed using an aspiration cannula (e.g., 3-4mm Mercedes or 14 gauge needle connected to a syringe), aspiration maybe performed alternatively using a cannula, such as cannula 184,optionally having an alternative tip configuration depending upon thedesired configuration for harvesting. The cannula 184 may be removedand/or replaced with another cannula for implantation, as previouslydescribed.

Additionally and/or alternatively, a cannula 184 incorporating thetissue detection assembly described herein may be used to facilitate theharvesting and extraction of the adipose tissue. In use, the cannula 184may be advanced into the patient's body and the detection system aspreviously described may be used to detect for the presence of fat forextraction.

Once the fat has been harvested, it may then be purified by extractingviable adipocytes from the lipoaspirate material. Typically, thelipoaspirate material may undergo centrifugation to separate theadipocytes from the blood, serum, damaged cells, tumescent fluids, oil,etc. and the extracted adipose graft material may be transferred tostandard syringes. Systems such as a VIAFILL™ (Lipose Corp., Maitland,Fla.) countertop centrifuge may be used to centrifuge and extract theadipocytes. A syringe, such as a short, broad 20 cc harvest syringe maybe used to manually extract the viable adipocytes where the plunger armmay be removed for centrifugation and the extracted fat may betransferred directly to any of the reservoirs described herein, such asreservoir 238, for direct implantation using any of the devicesdescribed herein.

Moreover, an optionally disposable in-line filtration device such asLIPIVAGE™ (Genesis Biosystems, Lewisville, Tex.) may be used to harvestthe fat. Such a device may be incorporated into the injection assemblyto extract and purify the extracted material, e.g., 20-25 cc of fat, byautomatically separating and washing the fat during the harvestingprocess utilizing internal filters. An example is shown in the side viewof FIG. 27 illustrating an in-line filtration device 270 having anextraction reservoir 272 which one or more filters 274 integrated intothe reservoir 272. The extracted material may be drawn into the devicefrom the patient and through cannula 184 where it may be separated andwashed. The purified fat contained within the reservoir 272 may then beremoved from the device 270 for implantation using the devices andmethods above or it may simply be injected directly into the patientusing the filtration device 270 incorporated into the sensing andinjection assemblies described above.

Further examples of in-line filtration devices and methods which may beincorporated into the injection assemblies herein are further shown anddescribed in, e.g., U.S. Pat. Nos. 4,753,634; 6,258,054; 7,588,732;7,780,649; and 7,794,449, each of which is incorporated herein byreference in its entirety.

Additionally and/or optionally, any of the injection assembliesdescribed herein may use multiple injection needles or cannulas, e.g.,two or more, extending from a single housing to increase the volumeand/or number of tracts per pass to increase the injectedvolume-per-surface ratio. These multiple cannulas may be arranged invarious configurations (e.g., adjacent in a planar arrangement) and mayuse multiple cannulas as practicable. An example is illustrated in theperspective view of FIG. 28A which shows two cannulas 184, 184′projection from handle 252 adjacent to one another. FIG. 28B showsanother example of three cannulas 184, 184′, 184″ projecting from handle252. Additional cannulas may be incorporated as desired and practicable.In each of the examples, the cannulas may be configured to beretractable within the handle 252 and/or may incorporate a movablepiston within each cannula as described herein for facilitate fatinjection into the body.

Another alternative variation is shown in the perspective view of FIG.28C which illustrates an injection instrument having a cannula 184 whichis interchangeable with a second cannula 184′.

FIGS. 29A and 29B show perspective views of yet another variation havingmultiple cannulas where each successive cannula may have a length whichis shorter to facilitate injection within a contoured body region suchas a breast. In this manner, a single insertion and injection may beaccomplished along curved regions of the breast without piercing throughentirely. For example, FIG. 29A shows an instrument assembly having afirst cannula 184 with a first length and an adjacent cannula 280 havinga second length which is shorter than the first length. FIG. 29B showsanother variation incorporating a third cannula 282 which has a thirdlength which is yet shorter than the second length of the second cannula280. Each length may be varied depending upon the desired lengths and/oranatomy of the body portion or breast to be injected. Moreover, each ofthese variations may incorporate retractable cannulas and/or movablepistons within the cannulas as described above.

FIGS. 30A and 30B show perspective views of yet another variation wherethe harvesting instrument assembly may incorporate a reconfigurablefiber optic attachment. In this example, the fiber optic assemblypositionable through the instrument may have a connection which isattachable to a cable assembly 300 at a first configuration, e.g.,extending from a side of the instrument. The cable assembly 300 may bedetached from the instrument and re-coupled into an axial configuration302. In this manner, the fiber optic assembly within the instrument maybe maintained as a modular system since cable assembly 302 may reconnectto the fiber optic assembly within the instrument.

In yet another variation, FIG. 31 shows a schematic illustration of acomplete fat harvesting, processing, and injection system which iscoupled to one another in a manner which provides a consistent andrelatively low pressure (e.g., a maximum pressure of 700 mmHg)throughout the entire harvesting, processing, and injection procedure.As shown, the fat 308 may be initially harvested via the instrument 310described herein. The harvested fat 308 may be drawn via a gentle vacuum312 and introduced into a pressurized processing reservoir 314. With thefat collected and processed within the reservoir 314, a pressure 316 anda vacuum 318 may be simultaneously imparted upon the fat 308 containedwithin the system such that the net force experienced by the processedfat is low or close to zero. The low pressure imparted on the fat helpsto maintain viability of the tissue.

With the fat drawn through the system, the processed fat may then bepressurized 320 for introduction 322 back into the selected region ofthe body. Accordingly, the entire procedure for harvesting, processing,and injection may be contained within a common closed system whichimparts a relatively low pressure to maintain tissue viability as wellas providing for a complete system which reduces or eliminates severalsteps. Additionally, the overall system further prevents the exposure ofthe adipose tissue to ambient air and to the environment to furtherreduce or minimize any additional trauma to the tissue. Moreover, thesystem may measure the pressure within the cannula, handle, or any ofthe other components during harvesting and/or injection, e.g., via anyof the processors or controllers described herein, to ensure that anytrauma upon the tissue is minimized. In the event that the monitoredpressure exceeds a predetermined level, the processor or controller maybe programmed to reduce the pressure, cease activity, or alert the userwith a visual and/or audio indicator.

Further examples of a combined fat harvesting and injection assembly areshown in the assembly view of FIG. 32. In this variation, a singlehandle 33 may be used with either a harvesting cannula 35 having the oneor more openings 37 and/or with a fat injection cannula 334 which may bedetachably removable via interface 332 to handle 33. The handle 33 maybe fluidly coupled via tube 43 to the harvesting reservoir 45 describedabove and the process may be controlled and/or monitored via a processor336 which may control the harvesting rates, pressures, flow rates, etc.as well as the injection parameters such as tissue identification,injection rates, etc.

Additionally and/or alternatively, in this and other variations thedetachable injection cannula 334 may be variously configured. Forexample the injection cannula 334 may be configured to have anintegrated plunger within a lumen of the cannula 334 and a retractablecannula which may be translated proximally relative to the handle 33 todeposit a known quantity of fat into the body along a tract formed bythe cannula itself. Examples of such a mechanism are described above,e.g., in FIGS. 23A to 23C.

Another example is shown in the assembly view of FIG. 33 whichillustrates how the handle 33 with the harvesting cannula 35 may be usedto harvest one or more cartridges 47 of fat and tissue from the patientbody. This harvested fat may be collected via the reservoir assembly 45and controlled by the processor 336. Once the fat has been desirablyprocessed, the cartridge 47 may be fluidly connected to the same handle33 or to a different handle and introduced into the patient body usingan injection cannula 334, as described above.

An example of a variation of the handle 33 is illustrated in theassembly view of FIG. 34, which shows handle 33 with cartridge 47coupled directly into the handle for introducing the fat into thepatient body. FIGS. 35A and 35B show perspective views of anothervariation of a handle assembly 340 attached to an injection cannula 334and further having an angled receiving section 342 for receiving anindividual cartridge 47 having processed fat for injection. The angledsection 342 may orient the cartridge 47 at an angle relative to thehandle 340 to facilitate the manipulation of the handle 340 as well asto facilitate the introduction and removal of the cartridge 47 from thehandle 340.

Yet another variation of a handle assembly 341 having an angledreceiving section 343 for receiving a cartridge 47 or reservoir, e.g.,syringe, is shown in the FIGS. 36A to 36J. In this variation, the handleassembly 341 may be configured as a portable and self-contained devicewhich may be used, in this example, to take the fat tissue containedwithin cartridge 47 and inject it into a patient body through theattachable injection cannula 334. Cartridge 47 may remain exposedrelative to the handle assembly 341 to provide immediate andunobstructed visual feedback to the user with respect to the tissuevolume remaining within the cartridge 47, as shown in the perspectiveand side views of FIGS. 36A and 36B, particularly during use forinjection into the patient body.

The cannula 334 may be coupled via cannula attachment 335 to cannulacoupler 345 which may extend from the angled receiving section 343 topresent a relatively small surface area at its outlet so as to maintainminimal patient contact. When cannula 334 is attached to handle assembly341, cannula 334 may project distally while off-set at a distancerelative to handle assembly 341. Moreover, the handle assembly 341 mayincorporate the receiving section 343 which may be angled relative tothe handle. The receiving section 343 may define a cartridge receivingchannel 351 which also defines a cartridge opening 353 which may beconfigured as a universal interface for receiving any number ofcartridge configurations, as shown in the perspective views of FIGS. 36Cand 36D. Cartridge receiving channel 351 and opening 353 may beoptionally interchangeable to receive any number of different cartridgeconfigurations if so desired.

Because the cannula 334 and cannula coupler 345 may be off-set relativeto the handle assembly 341, the receiving section 343 may continue to anoff-set attachment assembly 367 which may also define a control surface359 along a proximal portion for pressing one or more fingers against toprovide for leverage in pushing the assembly 341 in a distal direction,if needed, as shown in the side view of FIG. 36F. The cannula opening355 may also be seen in the end view of FIG. 36E for passing the fattissue through from the cartridge 47 and into and through the cannula334.

Additional control surfaces may be provided over the handle assembly 341for facilitating manipulation of the handle during use. For instance, atrigger guard 347 which may project at an angle from handle assembly 341may prevent inadvertent depression of the actuation trigger 349 and mayalso help to guide the user's fingers to the trigger 349 as well asprovides for a rest position for the user's fingers as well. Theactuation trigger 349 may be sized to provide space for one or morefingers of the user for pressing against to deliver the fat tissuethrough the cannula 334.

The handle assembly 341 may also define additional control surfaces suchas control surface 361 which may be curved between the interface of thehandle assembly 341 and angled receiving section 343 for providing asurface for the webbing between the user's thumb and fore finger.Control surface 365 may also be angled relative to the handle assembly341 and trigger guard 347 to provide for a manipulation surface by theuser's fingers. Additionally, one or more projections 363 may also beprovided along the handle assembly 363 to increase the gripping strengthof the user's hand against the handle assembly 341.

Additionally, the handle assembly 341 may also incorporate a controller357 (optionally lighted or able to be illuminated) which may be recessedrelative to the handle 341 to prevent inadvertent actuation. Thecontroller 357, as shown in the end and side views of FIGS. 36G and 36H,may be pressed to turn the assembly on or off as well as to control anynumber of aliquot delivery parameters, as described in further detailbelow. FIGS. 36I and 36J further illustrate top and bottom view of thehandle assembly 341.

FIGS. 37A and 37B show perspective views of another variation of thehandle assembly 340 illustrating how the handle may be separated into atleast two components. A resusable component 350 may contain the pumpingmechanism, electronics, controller, etc. and may be detachable coupledto a disposable portion containing the angled section 342 as well as thecartridge 47 and/or cannula 334.

FIGS. 38A and 38B illustrate perspective views of another variation of ahandle assembly 360 which may also comprise a resusable component 362 aswell as a disposable component 366 having an angled section 364 whichmay hold the cartridge 47 at a more acute angle relative to the handle360.

FIG. 39A schematically illustrates one example of how the individualcartridges 47 may be filled with the harvested fat collected from theharvesting cannula. As previously described, the harvesting assembly mayutilize one or more individual cartridges 47 which are fluidly open toreceiving the harvested material, as shown. Each of the cartridges 47may be detachable coupled to a base dock 370 and each cartridge 47 mayincorporate a valve 374 with a plunger 372 which remains in an openposition for receiving the harvested material introduced through thebase dock 370.

The individual cartridges 47 may generally comprise conventionalsyringes arranged in a consecutive fashion. The system may contain thebase dock 370 with several ports that allow each of the cartridges 47connected to fill with the fat. As the individual cartridges fill, theymay each close their respective plunger 372 to shut off the valve 374.

Fat may be transported into the cartridges 47 through the use of avacuum that is hooked into the base dock 370. The ports may be placed inseries allowing the fill of each consecutive syringe before moving on tothe next. Configuration of the cartridges 47 can be placed in line or ina circular fashion, so long as it is in series, as shown in theperspective assembly view of FIG. 40. When the harvesting procedure isfinished, cartridges 47 may have its respective fat fill. The user canthen remove the fat filled cartridges 47 and purge the air, as shown inFIG. 39B.

Each cartridge 47 may integrate its own plunger 372 throughout the lifethe device. The plunger 372 may allow for fat fill when the cartridge 47is engaged into the port adapter of the base dock 370. The fat may flowthrough the plunger 372 and around the valve 374, as shown in thecross-sectional side view of FIG. 41. Another variation is shown in thecross-sectional and perspective views of FIGS. 42A and 42B whichillustrate a plunger 372 defining one or more openings therethroughwhich may provide adequate space with a cross sectional area between,e.g., 0.15 to 0.20 in² for the fat to flow through, while maintainingthe integrity as a plunger.

The plunger 372 may also be used as a vacuum plunger when the device isplaced into the injection device. As the injection device draws the fat,the plunger 372 may move according to the vacuum rate, as shown in theside view of FIG. 43. The plunger 372 may incorporate O-rings 380 thatallow a dynamic seal, the ability to move while sealing against themating surface. With the vacuum pull of the injection device operatingless than 20 inHg, the plunger is able to move with less than 2.0 LbF ofpull.

The plunger 372 may further contain a piston valve 382 that ismechanically opened and automatically closed, as shown in thecross-sectional side views of FIGS. 44A and 44B. The sealing valve sizemay be tuned to allow fat flow when opened during the harvestingprocedure but also prevent air and liquid leakage when closed during theinjection procedure. The valve 382 outer diameter may be greater than,e.g., 0.626 in, to provide a seal. The valve 382 may be less than, e.g.,0.875 in, to allow flow around it. The distance to which the valve 382is moved away from the plunger 372 when opened is also tuned to allowfor easy fat fill. A distance of at least, e.g., 0.125 in, from gasketto plunger 372 to allow fat to flow through. The valve 382 may alsoinclude a soft gasket that may seal against the opening plunger 372.

The plunger 372 may be activated when the cartridge 47 is engaged intothe port adapters 384 which may be integrated into the base dock 370 forcoupling to the cartridges 47. The design concept incorporates the useof a spring that may close the valve 382 in a rest state. When actuated,the spring may compress, opening the valve 372 for fill, as shown in thecross-sectional side view of FIG. 45. When released, the force of thespring may provide at least, e.g., 2.0 LbF, to overcome the vacuum drawin the injection device. Force of the vacuum draw to move the plunger372 may be less than the force required to hold an air tight seal on thevalve or leakage may occur.

A key 390 may be incorporated into the design to hold the plunger 372 inplace while the cartridge 47 is engaged on to the adapter, as shown inthe perspective view of FIG. 46. After fill, the key 390 may be removedand discarded to allow the plunger 372 to move.

A perspective view of a port adapter 384 is shown in FIG. 47. Thevariation illustrated may incorporate flanges 392 to hold the cartridge47 against the base of the port 370 due to counter forces from thespring, which may pushes the cartridge 47 off the adapter 384. A staticO-ring 394 may be incorporated to provide a vacuum seal during fat fill.The bar may push the valve open when engaged.

An example of a reversible pump assembly 400 which may be integratedinto any of the handle variations described herein is shown in the sideand schematic side views of FIGS. 48A and 48B. The pump assembly 400shown may be integrated into any of the handle assemblies for use withthe detachable harvesting and/or injection cannula to provide forcontinuous and uninterrupted withdrawal of tissue from the body forharvesting or for continuous infusion of tissue for injection, asdescribed above. In either harvesting or injection, the vacuum pressureor injection pressure may be generated directly within the handle by thepump assembly 400 rather than relying upon a pumping mechanism separatedfrom the handle.

Moreover, because the pump assembly 400 both aspirates and dispenses thetissue simultaneously, the pump 400 makes it possible to continuallydeliver the tissue with no wait time and shortens the overall proceduretime.

The pump assembly 400 is shown as generally comprising a motor assembly404 coupled to the pump 402. A detachable reservoir 406, e.g., cartridge47, may be removably coupled via connection 408 to the pump 402. Thepump 402 may further define an opening 410 through which tissue may beharvested from the body and into the pump 402 or injected from the pump402 and into the body.

As illustrated in detail schematic of FIG. 48B, the motor assembly 404may have a motor 412, e.g., stepper motor, with an optional time relayor controller 414. The motor 412 may be rotatably attached, e.g., to arotatable lead screw 418, via a sealed motor coupling 416 where the leadscrew 418 is contained within a common chamber. A plunger 420translatably positioned upon the lead screw 418 may separate the commonchamber into a first chamber 422A and second chamber 422B which may bothbe variably sized depending upon the relative position of the plunger420 relative to the motor 412. When the lead screw 418 is rotated in afirst direction, the plunger 420 may be forced to translate in a firstdirection within the chamber and when the lead screw 418 is rotated in asecond opposite direction, the plunger 420 may accordingly translate ina second direction within the chamber opposite to the first direction.

In the case of tissue injection into the body, the detachable reservoir406 having a volume of harvested tissue for injection may be removablycoupled to a fluid channel 424. Fluid channel 424 may be fluidly coupledto the second chamber 422B via opening 426 and to fluid channel 434which is in communication with opening 410. A valve 428, e.g., one-wayvalve, located along fluid channel 424 may allow for the uni-directionalflow of tissue into second chamber 422B and a valve 432, e.g., one-wayvalve, located along fluid channel 430 coupling the reservoir 406 tofluid channel 434 may similarly allow for the uni-directional flow oftissue into and through fluid channel 434. A valve 436, e.g., one-wayvalve, positioned along fluid channel 434 may allow for theuni-direction flow of tissue from the first chamber 422A into andthrough fluid channel 434 and out of cannula 442. A fluid channel 438fluidly connecting second chamber 422B to fluid channel 434 may alsohave a valve 440, e.g., one-way valve, which allows for theuni-directional flow of tissue from second chamber 422B into and throughfluid channel 434.

In use, when the reservoir 406 is initially attached to the fluidchannel 424, motor 412 may be actuated to urge the plunger 420 in afirst direction, e.g., distally relative to the motor 412. As theplunger 420 moves along the first direction, a vacuum pressure generatedwithin second chamber 422B may draw the tissue from reservoir 406through channel 424 and through valve 428 and into second chamber 422B.Once the plunger 420 has been moved to a distal position along the leadscrew 418, the motor 412 may be reversed to turn the lead screw 418 in asecond opposite direction to force the plunger 420 to move in a secondopposite direction proximally towards the motor 412. The reversed motionof the plunger 420 may generate a vacuum pressure within first chamber422A to then draw the tissue from reservoir 406 through channel 430 andvalve 432 and into first chamber 422A. As the tissue is drawn into firstchamber 422A, the volume of tissue contained within second chamber 422Bmay be forced into channel 438 and through valve 440 and into channel434 and out of the cannula 442 for injection into the body. The one-wayvalve 428 may close to prevent the reintroduction of tissue from secondchamber 422B back into reservoir 406 and one-way valve 436 may likewiseclose to prevent the tissue passed through channel 438 from being drawnback into first chamber 422A.

As the plunger 420 reaches the end of its stroke, its direction mayagain be reversed to then urge the drawn volume of tissue within firstchamber 422A through valve 436 and through cannula 442 and into the bodywhile valve 432 and 440 may close to prevent the reintroduction of thetissue back into the reservoir 406. This process may be repeated in acontinuous manner such that the tissue from reservoir 406 may beinjected into the body in a continuous and uninterrupted flow regardlessof which direction the plunger 420 is moved. Alternatively, the valvesmay be reversed in direction to provide for harvesting of the tissuefrom the body through cannula 442 (harvesting cannula) and into pump 402for collection in reservoir 406 also in a continuous and uninterruptedmanner.

FIG. 49 shows a side view of another variation of the continuous pumpassembly 450. As shown, the first and second chambers 422A, 422B may beseen separated by the translatable plunger 420. In this example, thereservoir is detached and may be coupled via a separate channel, asshown.

To ensure a predictable amount of material is dispensed with eachstroke, the total travel of the plunger 420 may be sensed. One method isto use feedback from an encoder or controller, e.g., controller 414,attached to the drive motor 412. Another method to assess the positionof piston 420 is to monitor the current required to drive the piston420.

As shown in the exemplary graph of FIG. 50, the motor current may begraphed against a travel distance of the piston 420 within the chambers.As the piston travels between a proximal and distal end-of-travel (EOT)within the chamber, the current to the motor 412 changes with pistonposition. The signal moves up and down with changes in the powerrequired to move the piston 420. For example, the current signal mayincrease when a large sample moves through the system and may drop whena more fluid sample moves through the system. However, when the piston420 reaches the EOT, the piston 420 stops moving and the motor 412 drawsmore current to try and overcome the stalled piston 420. An internalelectrical circuit may detect when that current exceeds a thresholdcurrent 466 indicating that the piston 420 has reached EOT and reversethe direction of the motor 412. The process repeats when the currentthreshold 466 is exceeded when the piston 420 reaches EOT at theopposite end of the chamber.

FIG. 51A shows a perspective view of yet another variation of acontinuous pump assembly 470 removed from the handle for clarity. Inthis variation, the pump assembly 470 may incorporate a sensing andaliquot metering assembly within a proximal body 482 of the assembly, asdescribed in further detail below. The main chamber 472 positioneddistal to the proximal body 482 may contain the variable first chamber490A and second chamber 490B with a translatable plunger 492 positionedto slide therethrough. A distal body 474 may be attached distal to themain chamber 472 and may integrate a port 476 for attachment to achannel in fluid communication with the cartridge 47. The fat tissueheld within the cartridge 47 may flow into the port 476, through distalbody 474, and into and through the main chamber 472 (as previouslydescribed) for passage through angled channel 478, luer block 480, andthrough lumen 355 for introduction into the body via the cannula 334.

Motor 484 may be positioned at a proximal end of the pump assembly 470and may have a linear drive shaft 486 positioned through the motor 484for translation through the assembly 470 to actuate the plunger 492. Alinear position sensor circuit assembly 488 having a microprocessorand/or programmable logic device (such as a FPGA—fully programmable gatearray) platform may be positioned along the pump assembly 470 and mayfurther include sensor assemblies for detecting and/or controlling aposition of the plunger relative to the chamber 472.

FIGS. 51B and 51C show cross-sectional side and end views, respectively,of the pump assembly 470 with the circuit assembly 488 removed forclarity. As illustrated, motor 484 may have linear drive shaft 486positioned to pass through the motor 484 such that drive shaft 486 maybe translated linearly through the pump assembly 470 without rotatingabout its longitudinal axis via, e.g., an internal member such as a nutwhich may rotate within the motor 484 to translate the drive shaft 486rather than rotating it. Linear translation of the drive shaft 486rather than rotation of the shaft 486 may prevent any debris such asseptae, which may be present in the fat tissue being pumped through mainchamber 472, from wrapping or winding around the drive shaft 486 as itpasses through main chamber 472. Accumulation of debris about the driveshaft 486 may inhibit or prevent further movement of the drive shaft 486and reduce the pumping efficiency.

With the drive shaft 486 extending through motor 484, the distal end ofthe shaft 486 may be coupled to an interrupter assembly 496 through adrive shaft receiving channel 500. The interrupter assembly 496 may beconfigured as a slidable member which has a thin flag or projection 498extending from the member with a drive shaft receiving channel 500 andplunger shaft receiving channel 502 defined collinearly through theassembly 496 and parallel with the flag or projection 498. With thedistal end of the drive shaft 496 positioned within the receivingchannel 500, a proximal end of the plunger shaft 504 may be positionedwithin the plunger shaft receiving channel 502 collinearly aligned andadjacent. As the drive shaft 486 translates through the motor 484 andproximal body 482, the translational force may be transmitted via theinterrupter assembly 496 to the plunger shaft 504 and down to theplunger 492 which may translate through the main chamber 472 toeffectuate tissue injection. The plunger 492 may incorporate a seal 494around its periphery as well as a seal 506 along the plunger shaft 504along a pump barrier 508 between the main chamber 472 and proximal body482 to prevent or inhibit fluid from escaping from or between thechambers 490A, 490B.

Prior to and during fat tissue injection through the pump assembly 470,the circuit assembly 488 may initiate the device as well as control thealiquot delivery from the assembly 470. An example is shown in the endview of FIG. 52A and perspective cross-sectional side views of FIGS. 52Bto 52D which show the pump assembly 470 with the handle housing removedfor clarity. As illustrated in FIG. 52B, upon attaching the cartridge tothe handle assembly and turning the assembly on, the circuit assembly488 may start the motor 484 to position the plunger 492 in a primeposition where the plunger 492 is positioned proximally within the mainchamber 472 and where the flag or projection 498 or interrupter assembly496 is correspondingly positioned proximally within the proximal body482 such that the flag or projection 498 triggers or actuates a proximalsensor 510.

FIG. 52C illustrates an example of how the plunger 492 may be translatedthrough the main chamber 472 until its maximum travel distance has beenreached where first chamber 490A is expanded to receive fat tissue andthe corresponding second chamber 490B is compressed to inject the tissuecontained within. The flag or projection 498 is correspondinglytranslated through proximal body 492 until it triggers the distal sensor512 which may provide an indication to circuit assembly 488 that themaximum travel position has been reached.

FIG. 52D illustrates an example of the home position of plunger 492where both chambers 490A, 490B have been evacuated of any extraneous airor fluids and the device is ready for further actuation. The proximaledge of the flag or projection 498 may just interrupt the proximalsensor 510 to provide an indication to the circuit assembly 488 that thepump assembly 470 is in the home position and ready for further tissueinjection.

FIGS. 53A to 53C illustrate detailed side views of the proximal body 482to illustrate corresponding use of the proximal 510 and distal sensors512. As shown in FIG. 53A, the pump assembly has been initially actuatedto prime the main chamber 472 by positioning the plunger 492 in itsproximal position where the second chamber 490B is maximized and theflag or projection 498 is positioned to actuate proximal sensor 510. Adetail front and partial cross-sectional side view is further shown ofdistal sensor 512 to illustrate one variation of the sensor which may beused. The proximal sensor 510 and/or distal sensor 512 may be configuredas a yoke-shaped structure which defines a flag receiving channel 514through which the flag or projection 498 may pass. An infrared signalreceiver/emitter 516 may be positioned along one member for passing aninfrared beam between the members. Because the interrupter assembly 496may be fabricated from an opaque material (e.g., ABS plastic, metal,etc.), once the flag or projection 498 passes the receiver/emitter 516,the beam may be interrupted and indicate to the circuit assembly 488that the interrupter assembly 496 is in proximity to the proximal 510 ordistal sensor 512.

Although the proximal 510 or distal sensor 512 are illustrated asinfrared sensors, any number of alternative sensors may be utilized withthe devices described herein. For example, laser sensors, electricalcontacts, or any other suitable sensing mechanisms may be utilized.

Once the assembly 470 has been primed and powered, the trigger 349 maybe initially actuated to actuate the motor 484 to drive the shaft 486 tomove plunger 492 to a home position where the circuit assembly 488 mayregister a position of the plunger at zero. The drive shaft 486 may movethe flag or projection 498 distally until the proximal edge of the flag498 just interrupts the proximal sensor 510, as shown in FIG. 53B. Theplunger 492 may be correspondingly moved to its home position within themain chamber 472 ready to initiate tissue transfer through the first andsecond chambers 490A, 490B. As the trigger 349 is further actuated, themotor 484 may drive the drive shaft 486 distally to move interrupterassembly 496 and plunger 492 through the pump assembly 470 until theflag or projection 498 triggers the distal sensor 512 which acts as alimiting trigger, as shown in FIG. 53C. Upon detection of the flag orprojection 498 in its distal position, the circuit assembly 488 mayreverse the direction of the drive shaft 486 and plunger 492 to injectthe tissue contained within the first chamber 490A and to re-fill thetissue in second chamber 490B, as described above.

Aside from the transfer of linear motion from the drive shaft 486 to theplunger shaft 504 and plunger 492, the interrupter assembly 496 mayfurther function as a thermal insulator to prevent or inhibit heattransfer from the motor 484 to the tissue contained within the first andsecond chambers 490& 490B, as shown in the partial cross-sectional sideview of FIG. 54. Because the motor 484 can potentially reachtemperatures of around 120° C., cell death can result from exposure totemperatures greater than 37° C. The heat generated by the motor 484(e.g., 60%-80%) can conducted into and through the drive shaft 486.However, because of the separation between the drive shaft 486 andplunger shaft 504 and the minimal surface area contact between the shaftends and the interrupter assembly 496, which may be made from athermally insulating material such as ABS plastic, any heat conductionfrom the motor 484 via the drive shaft 486 and to the plunger shaft 504is minimal thereby preventing cell death from heat exposure.

FIG. 55A shows another perspective view of the pump assembly 470 withthe circuit assembly 488 removed for clarity. As shown, the interrupterassembly 496 with the flag or projection 498 may be seen slidablypositioned between the proximal sensor 510 and distal sensor 512. FIG.55B also shows a side view of distal cap 520 and angled channel 478which may cover the distal end of distal body 474. An end view of thedistal body 474 is also shown in FIG. 55C which illustrates channel 522,524 and their respective lumen openings 526A, 526B, 526C, 526D in fluidcommunication with port 476. Likewise, FIG. 55D shows an end view of themain chamber 472 with corresponding openings 526A′, 526B′, 526C′, 526D′for fluid coupling with the lumen openings 526A, 526B, 526C, 526D. Forall internal channels and ports, the respective diameters may rangeanywhere from, e.g., 0.050 in to 0.250 in, in this variation althoughother variations may include variable sized lumens.

However, when sizing the lengths and diameters of the ports and lumens(and surface finishes) as well as their positioning relative to oneanother, there are several factors for consideration in ensuring thatthe adipose tissue remains viable and survives during pumping andimplantation. For instance, such factors become relevant as they maydirectly impact the flow and shear stresses imparted upon the adiposetissue and ultimately determine whether the tissue survives theimplantation process.

A first consideration is the media, i.e., the pumped media may becomprised of adipose, connective tissue and possibly additives (mixed inprior to injection). The ports, lumens, and valves may be sized andpositioned to pass the colloid.

A second consideration is that the piston 492 may move at any number ofspeeds determined by the motor 484. The ports, lumens and valves may besized and positioned (as described above) to accommodate the pumpingspeed to ensure head losses do not lead to over pressurization orexcessive sheer stress on the media. That is, the port, lumen, andvalves dimensions described herein are particular to the delivery andpassage of the adipose tissue and are accordingly sized to ensure thatexcessive pressure is minimized on the tissue and hence to ensure tissueviability.

A third consideration is for valves that operate on pressuredifferentials, such as flapper or duck bill valves, where theorientation and positioning of these valves are essential to ensure thatcomponents such as septae pass through the valves without interferingwith the valve or the reciprocating pressures that open, close and sealthe flow paths. More specifically, flapper valves hinge from a positionof the lowest pressure (lowest flow) in the flow path to ensure septaepass the through the valve. Orienting the flapper improperly allows theseptae to catch on the flapper such that the septae may work its waytoward the hinge until the hinge is bound and the flapper fails.

One example is illustrated in the side and end view of FIG. 55E and 55Fwhich show a representative duck bill-type valve 525 positioned withinlumen 521 with adipose tissue 523 flowing through. Such valves 525 maybe located throughout the pumping assembly. The valve 525 may be seen inFIG. 55F where the valve leaflets are oriented to open in an up-downorientation relative to the flow path of tissue 523. Because the areaswhere the valve leaflets converge 527 represent pinching regions wherethe tissue 523 may accumulate and bind, orienting the valve 525 tomaintain the leaflets in the up-down orientation ensures that theconverging areas 527 are located along the sides where the tissue 523 isless likely to bind. If the converging areas 527 were rotated, e.g., 90degrees, such that the valve leaflets were oriented left-right relativeto the tissue flow, the tissue 523 may be more likely to accumulate andbind around the areas 527 thus fouling the valve 525.

Another example is shown in the side and end views of FIGS. 55G and 55Hwhich illustrate a representative flapper-type valve 529 which mayrotate about hinge 531. Similarly, valve 529, as it rotates toopen/close, may have converging areas 533 which may pinch the tissue asit flows and where the tissue may likely accumulate and bind. Having theconverging areas 533 oriented along the left-right of the valve 529 mayhelp to ensure that the tissue 523 is less likely to bind around thevalve 529. Similarly, if the converging areas 533 were rotated, e.g., 90degrees, such that the hinge 531 were oriented up-down, the tissue 523may be more likely to bind and foul the valve 529.

FIG. 55I shows a side view of an example where having the valve 529oriented in the manner shown and described may be particularly helpfulin reducing or inhibiting tissue from binding to or around the valve529. In this example, the flapper valve 529 may be hinged 531 along thetop relative to the tissue flow particularly where the lumen 521 maybend or curve upstream or downstream in proximity to the valve 529. Asillustrated, valve 529 may be hinged 531 to rotate upwardly relative tothe flow just proximal or upstream to where lumen 521 bends or curves,such as in a 90 degree bend. In other variations, valve 529 may bepositioned distal to the bend as well in the same manner as shown anddescribed. Positioning the hinge 531 opposite to the location shown anddescribed (i.e., 180 degrees from the position shown) may appear toensure a secure closure of the valve 529 in sealing properly by takingadvantage of a relatively large reciprocating pressure differential.However, positioning hinge 531 in such a manner may actually hinderproper closure of the valve 529 due to the difficulties in accumulatingtissue around the converging areas and may actually prevent adequatesealing of the valve 529.

A fourth consideration relates to form factor where once the ports,lumens and valves are properly sized and positioned, the form factor isdesirably small enough to fit within the confines of a hand-held devicethat keeps wasted media to a minimum. That is, the port, lumen, andvalve positioning as described herein is sized and located to ensurethat the assembly is optimally sized for configuring into the hand-heldassembly shown, for instance, in FIGS. 36A to 36J.

Moreover, while these considerations are generally for adipose tissueand its particular composition, they may also apply to other materialssuch as colloids where the tissue is comprised of autologous tissue andone or more supplements added to improve the graft's performance.

As previously described, while the flag or projection 498 acts as alinear encoder, the assembly may further incorporate a linear positionsensor 530, e.g., FSLR position sensing resistor, positioned along theproximal body. Interrupter assembly 496 may incorporate a plunger 532,e.g., ball plunger, which maintains a force upon the linear positionsensor 530 as the interrupter assembly 496 traverses through theproximal body, as shown in the partial cross-sectional side views ofFIGS. 56A and 56B. The position of the plunger 532 upon the linearposition sensor 530 may provide the position of the interrupter assembly496 and hence the plunger position within the main chamber 472 at alltimes to the circuit assembly 488.

As shown in FIG. 56A, the initial prime position 534 may correspond with0.0 V as a starting condition and the home position may correspond with0.75 V as output by the linear position sensor 530 and as registered bythe processor on circuit assembly 488. Once the pump assembly 470 isturned on, primed, and moved into the home position 536, i.e., adistance D0 from the initial prime position 534 to the home position536, the circuit assembly 488 may begin to measure and compare voltagesat each subsequent position along the linear position sensor 530 andcompare the relative differences. For instance, the plunger 492 may beprogrammed to move in a stepped manner such that the plunger 492 movesfrom its home position P0 to any number of subsequent stepped positionP1 P2, P3, P4, P5 corresponding to each volume pumped from the assembly470, as shown in FIG. 56C. If those measured differences remainconsistent, the pump is operating correctly. However, if the differencesbegin to read differently, e.g., relatively lower, then this may be anindication that the pump is malfunctioning or this may indicate thepresence of a clog in the pump.

As the plunger 492 translates, it may be translate at a rate sufficientto pump the tissue anywhere between, e.g., 0.1 to 2.5 cc per second,without damaging the tissue. Moreover, the pumping system may maintainan internal pressure between, e.g., 15 inHg (vacuum) and 51 inHg(pressure).

The circuit assembly 488 may constantly check for clogs and whether theyhave been cleared. Each time an aliquot is dispensed and the piston 492stops (e.g., at subsequent stepped position P1, P2, P3, P4, P5, etc.) anassociated piston position value (count) may be stored in the circuitassembly 488 and compared with previous aliquot counts. Under normaloperation, the count change is repeatable within some tolerance (thetolerance accounts for any system hysteresis or manufacturing/componentvariation). When a clog develops, pressure builds and the piston 492 maynot move as far as it should, the resulting count falls out of thetolerance range and a clog is indicated. When a clog clears (either onits own or with outside intervention such as by replacing the cannula),the counts fall back within normal tolerances and the clog flag clears.

Clog detection becomes more complex with the pump's capability ofdelivering two different sized aliquot as well as a platform that can beprogrammed to provide a range of predetermined aliquot sizes to selectfrom. Consequently, the clog detection scheme may also be equallyflexible.

The circuit assembly 488 may provide this flexibility by comparing thecounts of consecutively stored position counts and programmed parametersto detect clogs (and clears). Clogs may be flagged if an out oftolerance condition has occurred within any of the previous aliquotdeliveries, e.g., 1 to last 8 aliquots. An all-clear signal may beflagged in a similar manner and has priority to a flagged clog. Forexample, assuming the circuit assembly 488 is programmed to look backN=6 aliquots for clogs and N=2 for cleared, every time the piston 492stops, the count may be recorded and circuit assembly 488 may examinethe difference between the current count and the previous 6 aliquotcounts. If the count comparison is out of range, a clog is flagged. Nextthe count comparison is made 2 aliquot counts back and if it is withinthe tolerance range, then an all-clear signal is provided and anyprevious clog flag may be cleared and no clog is indicated. If thedifference is out of range and the clog flag is set, a clog isindicated.

Since aliquot parameters are stored in the device for the pre-programmedaliquot sizes, when the user selects a different aliquot size, the newparameters may be used to evaluate clog/clear conditions for the newsize without the need to restart or home the device.

In the event of a clog or obstruction in the pump, a visual or audibleindicator or alarm may alert the user. For instance, an LED board 550located along luer block 480, as shown below in FIG. 58A, mayilluminate. Additionally, if the clog appears to have cleared (either onits own or manually) and the voltage differences return to a consistentlevel, then the indicator or alarm may shut itself off.

The motor 484 can be controlled by circuit assembly 488 to be driven adefined amount of steps that equate to the desired dispersement volumeof tissue. The number of aliquots that can be pumped without changingthe direction of the motor 484 may be defined by the aliquot volume andthe number of steps needed. For instance, if one aliquot of a 0.5 ccvolume of tissue requires 100 steps of the motor 484 and plunger 492 fordispensing from the pump and the total number of steps available in asingle pumping direction is set at 450, then the processor on thecircuit assembly 488 may determine that the pump assembly 470 canproduce four 0.5 cc aliquots before having to switch motor direction.Avoiding directional changes of the pump mid-delivery of an aliquot mayhelp to avoid any directional-change related inconsistencies in volumesize delivered. However, even in the motor 484 requires switching of itsdirection, the tissue volume dispensed may remain continuous andaccurate during tissue injection.

Additionally, the circuit assembly 488 may be programmed toautomatically advance the plunger 492 a pre-determined number of stepsfor metered aliquot delivery. For example, each time the actuationtrigger 349 is depressed, the plunger 492 may advance in “small” or“large” steps until a pre-determined number of steps or pre-determinedvolume is delivered. By depressing the controller 357 once or twice orsome pre-determined number of times, the circuit assembly 488 may beprogrammed to accept a relatively small or large aliquot delivery perstep while the actuation trigger 349 remains depressed. For instance,the aliquot volume may range for delivery of 0.5 cc or 1.0 cc per stepor smaller increments of 0.2 cc or 0.4 cc per step or any otherincrements so desired.

The circuit assembly 488 and microprocessor may be programmed to avoidmid-aliquot direction changes by utilizing a “look ahead” feature. Whenthe pump is initially turned on and the piston 492 moves out of itsprime position, the assembly 488 may remember the home position. Sincethe total cylinder stroke length is known by design, the assembly 488“knows” where the piston 492 is relative to home as it moves back andforth through the cylinder during the pumping process. Before pumpingthe next aliquot, the assembly 488 “looks ahead” to see if there isenough travel to dispense a complete aliquot. If there is, the piston492 may continue in its direction of travel. If there is not enoughtravel, the piston 492 may automatically reverse and starts pumping inthe opposite direction.

While this approach addresses the majority of aliquots, there are threeother alternative conditions. The first condition is the pre-programmedaliquot that is larger than can be delivered in a single stroke throughthe cylinder rendering the “look ahead” feature potentiallyinapplicable. For this case, a number of parameters may be added toaccount for any inconsistencies that may be related to a directionalchange. Specifically, the piston 492 may be over-driven by apredetermined amount (e.g., defined by unique variables for proximal anddistal direction and for predetermined aliquot sizes) thereby deliveringthe added material lost during a directional change.

The second condition to address is when the actual piston location mayloses sync with the known location which can happen when the steppermotor 484 slips such as when the pump clogs. In this case, the piston492 will eventually reach the distal end of travel limit switch wherethe piston location is resynchronized and the end-of-travel parametersdefine how much farther the piston 492 must travel in the oppositedirection to complete the aliquot.

The third condition addresses what happens if aliquot size is changedduring the procedure. If the aliquot size is changed mid-procedure, thecircuit assembly 488 may determine which way the piston 492 should moveimmediately after the change and whether it can accommodate the changeor whether it will over-drive the piston displacement to ensure thedesired aliquot size is delivered. In the event the piston 492 is notwhere it is expected, the end-of-travel limit switch resynchronizes thepiston location with its home position to ensure all the aliquot sizesare consistent.

The volumes and steps described above are intended to be illustrative ofthe various parameters which may be adjusted by the user with thedevices described herein. Hence, the number of steps per triggeractuation as well as the volume dispensed per step (aliquot volume),step rate, dwell time, etc., may be varied over any suitable rangedepending upon the desired application and volume to be dispensed.Moreover, stepped advancement of the plunger 492 as well as adjustmentof the number of steps may be applied to any of the embodimentsdescribed herein.

Aside from controlling advancement of the plunger 492, another featurewhich may be incorporated into any of the embodiments herein is shown inthe detail side views of FIGS. 57A and 57B. When tissue is introducedinto the chambers 490A, 490W entrapped air or debris 540 may accumulatewithin one or both chambers 490A, 490B particularly because of thecircumferential seal 494 around plunger 492. To remove this air ordebris 540, a proximal portion of the pumping chamber may be made tohave a priming bore diameter PD, e.g., 0.520 in., which is larger thanthe bore diameter BD, e.g., 0.500 in., of the chambers 490A, 490B. Thediameters are provided as examples of the amount of clearance which canbe provided and the diameter differences and are not intended to belimiting.

The area around the priming bore diameter PD may be in fluidcommunication through port or opening 548 in fluid communication withfluid channel 546 through which the tissue within chamber 490A may bepumped through. The priming bore diameter PD may provide enoughclearance for the seal 494 such that when plunger 492 is initially movedinto its primed positioned (as described above) the air or debris 540from one or both chambers 490A, 490B may escape through the port oropening 548, as shown in FIG. 57B, and avoid being injected into thepatient body. Also shown are the bonded pump joint 542 and shaft seal544.

Because sufficient clearance is provided around the seal 494 whenpositioned in its primed location within the priming bore diameter PD,the free lipids within the fat tissue are able to wick around the seal494 and also provide lubrication to the seal 494 as it traverses throughthe main chamber 472. Hence, the pumping assembly may be provided to auser with the plunger 492 and seal 494 positioned in its primedlocation, as shown in FIG. 57B, which will prevent the seal 494 fromtaking a set if otherwise compressed. Additionally, because the fattissue introduced into the system may act as the lubricant itself, thepumping system may be provided without any additional lubrication.

Yet another feature which may be incorporated into any of the variationsdescribed herein to the extent practicable is shown in the side anddetailed perspective views of FIGS. 58A and 58B. As shown, theattachment of the cannula to the pumping assembly may also incorporate afeature which decouples or isolates any forces applied to the cannulafrom the rest of the pumping assembly. One variation is shown in theside view of FIG. 58A which illustrates the angled channel 478 and luerblock 480. The cannula coupler 345 may connect to a cannula such thatthe forces applied to the cannula during attachment and use aredecoupled from the main chamber but preserve the fluid communicationthrough lumen 355. The angled channel 478, having a distal cap 558attached thereto, and luer block 480 may be attached via attachments552, 554, 556 (e.g., bonding, interference fit, etc.) and maintain alongitudinal axis of luer block 480 separated or off-set from alongitudinal axis of the main chamber.

As previously described, a visual or audible indicator or alarm such asLED board 550, may be attached proximal to the cannula coupler 345 andmay light or flash as an indication that a clog may be present in thelumen 355 or cannula. Other variations of LED board 550 may be used inalternative examples.

As illustrated in the perspective view of FIG. 58B, luer block 480 mayalso be secured within the bottom portion of handle 566 to furtherprevent the transmission of forces placed upon the couple 345 from beingrelayed or imparted to the main chamber. The bottom portion of handle566 may thus define side channels 560, 562 and a proximal stop 564within which luer block 480 may rest. As shown in the illustrative endview of FIG. 58C, once luer block 480 is positioned within the channel,the contacting walls of the handle against the luer block 480 mayprevent rotation of the block 480 in any of the rotational axes, i.e.,X, Y, or Z axes. Moreover, once the top portion of handle 568 is placedupon the pump assembly and luer block 480, the luer block 480 and anyforces imparted upon the cannula and luer block 480 itself may beprevented from further transmission.

Further examples and variations of the harvesting instrument as well asprocessing and guidance and also injection devices and methods arefurther described in the following description and figures, which isincorporated herein in its entirety.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modification ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

What is claimed is:
 1. A tissue pumping system, comprising: a mainchamber having a plunger slidably translatable within; an injectioncannula in fluid communication with the main chamber; a motor incommunication with the plunger; and a circuit assembly having amicroprocessor in electrical communication with the motor, wherein themicroprocessor is programmed to actuate the motor such that the plungeris advanced through the main chamber in a stepped manner where each stepdefines a predetermined volume of tissue for injection through thecannula, and wherein the microprocessor is further programmed to changea direction of the plunger within the main chamber depending upon aremaining volume of tissue to be injected through the cannula whilemaintaining the predetermined volume of tissue in each step.
 2. Thesystem of claim 1 further comprising a proximal body positioned betweenthe main chamber and the motor.
 3. The system of claim 2 furthercomprising an interrupter assembly slidably positioned within theproximal body and attached to the plunger via a plunger shaft.
 4. Thesystem of claim 3 further comprising a drive shaft coupled to the motorand the interrupter assembly.
 5. The system of claim 4 wherein theinterrupter assembly is comprised of a thermal insulating material. 6.The system of claim 3 further comprising at least two limiting triggerseach positioned at proximal and distal ends of the proximal body,wherein the interrupter assembly is slidably positioned to interrupteach of the limiting triggers.
 7. The system of claim 6 wherein thelimiting triggers comprise optical sensors.
 8. The system of claim 3further comprising a position sensor adjacent to the interrupterassembly and in communication with the microprocessor, where interrupterassembly maintains contact with the position sensor during lineartranslation.
 9. The system of claim 1 wherein the main chamber defines afirst diameter along a portion of the main chamber and a second diameteralong a proximal portion of the main chamber, where the second diameteris larger than the first diameter and in fluid communication with aport.
 10. The system of claim 1 further comprising an angled lumen and aluer block in fluid communication between the main chamber and theinjection cannula, where the luer block is positioned off-set relativeto the main chamber such that a force imparted upon the cannula isisolated from the main chamber.
 11. The system of claim 1 furthercomprising a reservoir which is fluidly connectable to the main chamber.12. The system of claim 11 wherein the reservoir contains a volume oftissue visible to a user.
 13. A tissue pumping system, comprising: amain chamber having a plunger slidably translatable within; a proximalbody positioned adjacent to the main chamber; an interrupter assemblyslidably positioned within the proximal body and attached to the plungervia a plunger shaft; at least two limiting triggers each positioned atproximal and distal ends of the proximal body, wherein the interrupterassembly is slidably positioned to interrupt each of the limitingtriggers; and a circuit assembly having a microprocessor in electricalcommunication with a motor, wherein the microprocessor is programmed totranslate the interrupter assembly through the main chamber and betweenthe limiting triggers.
 14. The system of claim 13 wherein the circuitassembly is further programmed to translate the interrupter assembly ina stepped manner where each step defines a predetermined volume oftissue for injection from the main chamber.
 15. The system of claim 13further comprising an injection cannula in fluid communication with themain chamber.
 16. The system of claim 13 wherein the microprocessor isfurther programmed to change a direction of the plunger within the mainchamber depending upon a remaining volume of tissue to be injected whilemaintaining the predetermined volume of tissue in each step.
 17. Thesystem of claim 13 further comprising a position sensor adjacent to theinterrupter assembly and in communication with the microprocessor, whereinterrupter assembly maintains contact with the position sensor duringlinear translation.
 18. The system of claim 13 further comprising adrive shaft coupled to the motor and the interrupter assembly.
 19. Thesystem of claim 13 wherein the interrupter assembly is comprised of athermal insulating material.
 20. The system of claim 13 wherein thelimiting triggers comprise optical sensors.
 21. The system of claim 13wherein the main chamber defines a first diameter along a portion of themain chamber and a second diameter along a proximal portion of the mainchamber, where the second diameter is larger than the first diameter andin fluid communication with a port.
 22. The system of claim 13 furthercomprising an angled lumen and a luer block in fluid communicationbetween the main chamber and an injection cannula, where the luer blockis positioned off-set relative to the main chamber such that a forceimparted upon the cannula is isolated from the main chamber.
 23. Thesystem of claim 13 further comprising a reservoir which is fluidlyconnectable to the main chamber.
 24. The system of claim 23 wherein thereservoir contains a volume of tissue visible to a user.
 25. The systemof claim 13 wherein the plunger translates at a rate sufficient to pumptissue between 0.1 to 2.5 cc per second without damage to the tissue.26. The system of claim 13 wherein the plunger translates such that thepumping system maintains an internal pressure between 15 inHg and 51inHg.
 27. The system of claim 13 further comprising an actuation triggerin communication with the circuit assembly.
 28. The system of claim 27further comprising a guard in proximity to the actuation trigger,wherein the guard prevents unintended activation.
 29. A method ofinjecting a volume of tissue into a body, comprising: introducing avolume of tissue into a main chamber of a tissue pumping system;translating a plunger through the main chamber in a first direction in astepped manner, where each step defines a predetermined volume oftissue; monitoring a position of the plunger relative to the mainchamber while further monitoring a volume dispensed from the mainchamber via a microprocessor; and reversing a direction of the plungersuch that the plunger is translated through the main chamber in a seconddirection opposite to the first direction, wherein the plunger istranslated in the stepped manner in the second direction.
 30. The methodof claim 29 wherein introducing a volume of tissue comprises coupling acartridge having a volume tissue into fluid communication with the mainchamber.
 31. The method of claim 29 further comprising injecting thevolume of tissue into the body via an injection cannula in fluidcommunication with the main chamber.
 32. The method of claim 31 furthercomprising isolating a force imparted upon the main chamber by theinjection cannula via a luer block positioned off-set relative to themain chamber.
 33. The method of claim 29 wherein translating a plungerthrough the main chamber further comprises thermally insulating thevolume of tissue within the main chamber via an interrupter assembly.34. The method of claim 29 wherein monitoring a position of the plungercomprises sensing a position of the plunger via a position sensoradjacent to an interrupter assembly and in communication with themicroprocessor, where interrupter assembly maintains contact with theposition sensor during linear translation.
 35. The method of claim 29wherein reversing a direction of the plunger comprises triggering themicroprocessor via a sensor sensing an interrupter assembly coupled tothe plunger.
 36. The method of claim 35 wherein the interrupter assemblycomprises a flag or projection extending from the interrupter, where thesensor is triggered via the flag or projection.
 37. The method of claim29 wherein reversing a direction of the plunger comprises sensing anumber of steps translated by the plunger and reversing the directionupon completion of a step.
 38. The method of claim 29 further comprisingdetermining whether the position of the plunger and the volume dispensedcorrespond to one another via the microprocessor.
 39. The method ofclaim 38 further comprising providing a visual or audible indication ofa presence of a clog upon detection of non-correspondence between theposition of the plunger and the volume.
 40. The method of claim 29 wherethe volume of tissue is comprised of autologous tissue and supplements.